The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified May 2014 by Rosario D'anna, University of Messina. Recruitment status was: Recruiting

Sponsor:

University of Messina

ClinicalTrials.gov Identifier:

NCT01046500

First Posted: January 12, 2010

Last Update Posted: May 20, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. One hundred post-menopausal women from 50 to 60 years old, affected by metabolic syndrome (criteria are described in NIH ATP III) will be randomized into two groups: 50 treated with myo-inositol 2 g twice per day and fifty treated with metformin for six months. Metformin is the drug usually used in diabetic and pre-diabetic conditions, as metabolic syndrome. The investigators hypothesize that the administration of myo-inositol would improve the insulin-receptor activity in these women, reducing insulin resistance as well as metformin.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

50 Years to 60 Years (Adult)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Post-menopausal outpatients affected by the metabolic syndrome, whose criteria are described in NIH ATP III, 2001.

Exclusion Criteria:

Post-menopausal outpatients without metabolic syndrome

assumption of hypocholesterolemic or other insulin sensitizing drugs

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046500